1037-Principal Statistical Programmer Consultant-remote
Skills
- Expert SAS programming and report generation skills
- Strong knowledge of CDISC standards (SDTM/ADaM) and clinical data structure
- Experience in FDA-regulated environment with Clinical Study Reports and NDA submissions
- Therapeutic area experience in Rare Disease (required)
- Program validation, documentation, and adherence to programming standards
- Ability to coordinate with vendors and CROs and manage multiple tasks to deadlines
- Excellent verbal and written communication and cross-functional collaboration
Responsibilities
- Participate in CRF design, database review, data management plan and data review processes
- Produce data listings, summary tables, and graphics (TFLs) for interim and final analyses
- Integrate data across studies within a project and validate analysis datasets
- Test, document, review, and validate programs according to department guidelines
- Coordinate data transfer and programming standards with CROs and external vendors
- Validate analysis datasets and TFLs delivered by vendors
- Collaborate with biometrics/statistics for analysis activities and regulatory deliverables
- Support ad-hoc requests, manuscripts, posters, and client-facing presentations
Education
- BA/BS in Computer Science, Statistics, Mathematics or related field (required)
- MA/MS in related field acceptable with reduced experience threshold (per job spec)
Benefits
- Opportunity to work directly for a sponsor while accessing global CRO resources
- Professional development and continuous training
- Supportive, low-turnover culture with career growth opportunities
- Remote work flexibility
- Inclusive and diverse workplace
Average salary estimate
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